MAUDE Adverse Event Report: AESCULAP INC PRESTIGE ATRA GRASPER DBL-ACT 5MM; REUSABLE INSTRUMENTS

Model Number 8360-10

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional " the doctor was attempting to grasp the round ligament, and the device would not hold the grip." this incident did not cause or contribute to a serious injury, death or a delay in surgery.There was no additional intervention required.

Manufacturer Narrative

Manufacturing site evaluation: a 100% visual inspection is performed for braze quality as defined by brazing subassembly instructions.A 100% torque test is performed for braze strength and visual of braze quality as defined by sub-assembly torque testing procedure.There were no rejects reported for braze failures during the testing of this lot.However, it was determined that there was no method to report scrap at the brazing operation.Therefore, it is unknown if there were increased failures during this lot.A 100% final inspection is performed which includes grip test with no reported failures for this lot.We believe that had the defect been present at the time of shipment, the inspection methods would have captured the defect.Therefore it is believed that the defect was not present at the time of shipment.However, the strength for the braze could have been not sufficient to withstand use within the field.During manufacturing of the complaint lot, we also incorporated an additional inspection of a variable first piece inspection per lot of the braze strength thru a destructive test on instron as per brazing pull test.The specification limit set for this is greater than 650 lbf.The implementation of the test was the result of (b)(4), which validated the implementation of flux during the brazing operation and identified a large range in strength results when brazing without flux.Root cause for occurence: investigation showed that defects related to the brazing process and determined that the complaint lot was manufactured prior to the implementation of flux.The implementation of flux was performed on (b)(6) 2018 as a result of the similar defect as the complaint (clean break at the braze join between the tube and the dovetail housing).Therefore the suspected root cause for occurence is the brazing operation being performed without flux.Corrective action for occurence: the root cause was determined to be related to the parts being processed prior to the implementation of flux.Since the shipment lot, the validation of the incorporation of flux was performed on all brazing operations.Therefore there are no corrective actions required for occurence.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8316900
• MDR Text Key: 135424031
• Report Number: 2916714-2019-00001
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Device Lot Number: M45399
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/11/2019
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1